Hemodialysis PatientsNCT04645459
The Influence of Low Phosphorus in Hemodialysis Patients
A study testing low phosphorus meals in people with Hemodialysis Patients, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Consuming high levels of dietary phosphate and poor adherence of phosphate-binding-therapy might induce hyperphosphatemia in the hemodialysis (HD) patients. Therefore, the risks of Chronic Kidney Disease-related Mineral and Bone Disorders (CKD-MBDs) and inflammation will be increased. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hemodialysis Patients
- What is being tested?
- low phosphorus meals
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Dec 2020to 28 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemodialysis patients, ≥ 20 years of age
Who cannot join
- ≥ 80 years of age, liver cirrhosis, cancer, pregnancy, vegetarian
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Shuang Ho Hospital
New Taipei City
Mai-Szu Wu, +886(2)28837300, maiszuwu@tmu.edu.tw
About this study
Official title: The Influence of Low Phosphorus Meals on Serum Phosphorus Concentration and Inflammatory Indicators in Hemodialysis Patients
Consuming high levels of dietary phosphate and poor adherence of phosphate-binding-therapy might induce hyperphosphatemia in the hemodialysis (HD) patients. Therefore, the risks of Chronic Kidney Disease-related Mineral and Bone Disorders (CKD-MBDs) and inflammation will be increased. This double blind and intervention randomized controlled trial study will be designed to investigate the hypothesis that if low phosphorus meals decrease serum phosphorus concentration and inflammatory indicators. A total of 80 HD patients in the HD center of Shuang Ho Hospital will be recruited and be assigned to low phosphorus meal group (LP group) and control group randomly before one-week-washout period. The subjects of LP group and control group will consume low phosphorus meals and standard meals respectively. During washout period and study period, all subjects will continue to consume their regular breakfast and take one tablet of calcium carbonate with meal. All data will be collected at baseline, one week after the washout period, and the end of the 7-days-study period. The indicators are including dietary contents, phosphate binder administration, indicators of dialysis adequacy, nutritional indicators, blood lipid indicators, biochemical indicators, CKD-MBDs indicators, and inflammation indicators. Data were analyzed by Statistical Product and Service Solutions program version 18. Paired t-test, Student's t-test, Pearson correlation coefficient and Logistic regression will be used. P < 0.05 will be considered as statistically significant.
Read the detailed description
Study Design and Subjects:
This study was design as a randomized, double-blind control trail. A total of 80 HD patients were recruited from the HD center of Taipei Medical University-Shuang Ho Hospital in Taiwan. The inclusion criteria were including ≧20 years old and non vegetarian. The exclusion criteria are including liver dysfunction, cancer and pregnancy.
Dietary Intervention:
All subjects followed their usual diets but took one tablet of calcium carbonate as phosphate binder per meal for the first week washout diet. After washout diet, subjects were assign to control or study group randomly and entered to the study period for one week. The diets of the study group were low phosphorus ( LP group), but the dietary phosphorous levels of the control group were not modified. During the study period, all subjects including LP group and control group still kept their usually accustomed behavior about regular breakfast and also took one tablet of calcium carbonate as phosphate binder with every breakfast meal. The LP group and control group replaced daily lunch and dinner with low phosphorus and standard meals respectively and should not take any phosphate binder during the study period for one week.
For controlling the volumes of proteins, phosphorus and calcium easily, the main courses of both of the study and the control meals were made by a central kitchen. All of the meals contained 3 exchanges of protein (25 g) and 1 exchange of vegetable. There were 5 main courses for the both diets. The proteins of the study meals had been removed by an average 20 -30% of the phosphorus through boiling the meats before cooking process. But the boiling method did not process for the control meals. Every meal including all the study and the control meals contained one tablet of calcium carbonate. As a consequence, the additional phosphate binders should not be taken while eating the study meals. The subjects had to prepare carbohydrate by themselves, and they could choose any source of carbohydrate as their wants.
Data Collection:
The personal characteristics and the anthropometry data were collected at baseline. All data were collected at baseline, one week after the washout period, and the end of the 7-days-study period. The indicators were including dietary contents, phosphate binder administration, dialysis adequacy, nutritional indicators, blood lipid indicators, biochemical indicators, CKD-MBDs indicators, and inflammation indicators.
- Conditions
- Hemodialysis Patients
- Being tested
- low phosphorus meals, control meals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low phosphorus mealsOther
All subjects followed their usual diets but took one tablet of calcium carbonate as phosphate binder per meal for the first week washout diet. After washout diet, subjects were assign to control or study group randomly and entered to the study period for one week. The diets of the study group were low phosphorus ( LP group), but the dietary phosphorous levels of the control group were not modified. During the study period, all subjects including LP group and control group still kept their usually accustomed behavior about regular breakfast and also took one tablet of calcium carbonate as phosphate binder with every breakfast meal. The LP group and control group replaced daily lunch and dinner with low phosphorus and standard meals respectively and should not take any phosphate binder during the study period for one week.
control mealsOther
All subjects followed their usual diets but took one tablet of calcium carbonate as phosphate binder per meal for the first week washout diet. After washout diet, subjects were assign to control or study group randomly and entered to the study period for one week. The diets of the study group were low phosphorus ( LP group), but the dietary phosphorous levels of the control group were not modified. During the study period, all subjects including LP group and control group still kept their usually accustomed behavior about regular breakfast and also took one tablet of calcium carbonate as phosphate binder with every breakfast meal. The LP group and control group replaced daily lunch and dinner with low phosphorus and standard meals respectively and should not take any phosphate binder during the study period for one week.
| Study group | Role | What they receive |
|---|---|---|
| low phosphorus meal group (LP group) | Experimental | The proteins of the low phosphorus meal had been removed by an average 20 -30% of the phosphorus through boiling the meats before cooking process. Receives: Other: low phosphorus meals |
| control group | Placebo comparator | The boiling method did not process for the control meals. Receives: Other: control meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
anthropometric measurement
body height (cm)
Measured: baseline
anthropometric measurement
body height (cm)
Measured: one week after the washout period
anthropometric measurement
body height (cm)
Measured: the end of the 7-days-study period
anthropometric measurement
body weight before hemodialysis (Kg), dry weight (Kg)
Measured: baseline
anthropometric measurement
body weight before hemodialysis (Kg), dry weight (Kg)
Measured: one week after the washout period
anthropometric measurement
body weight before hemodialysis (Kg), dry weight (Kg)
Measured: the end of the 7-days-study period
blood pressure
systolic blood pressure (mmHg), diastolic blood pressure (mmHg)
Measured: baseline
blood pressure
systolic blood pressure (mmHg), diastolic blood pressure (mmHg)
Measured: one week after the washout period
blood pressure
systolic blood pressure (mmHg), diastolic blood pressure (mmHg)
Measured: the end of the 7-days-study period
dietary contents
24-hour dietary recall
Measured: baseline
dietary contents
24-hour dietary recall
Measured: one week after the washout period
dietary contents
24-hour dietary recall
Measured: the end of the 7-days-study period
phosphate binder administration
type and dosing frequency
Measured: baseline
phosphate binder administration
type and dosing frequency
Measured: one week after the washout period
phosphate binder administration
type and dosing frequency
Measured: the end of the 7-days-study period
indicators of dialysis adequacy
Kt/V
Measured: baseline
indicators of dialysis adequacy
Kt/V
Measured: one week after the washout period
indicators of dialysis adequacy
Kt/V
Measured: the end of the 7-days-study period
blood lipid indicators
LDL(mg/dL), HDL (mg/dL) , cholesterol (mg/dL) , triglyceride (mg/dL)
Measured: baseline
blood lipid indicators
LDL(mg/dL), HDL (mg/dL) , cholesterol (mg/dL) , triglyceride (mg/dL)
Measured: one week after the washout period
blood lipid indicators
LDL(mg/dL), HDL (mg/dL) , cholesterol (mg/dL) , triglyceride (mg/dL)
Measured: the end of the 7-days-study period
biochemical indicators
normalized protein equivalent of total nitrogen appearance(g/kg/d)
Measured: baseline
biochemical indicators
normalized protein equivalent of total nitrogen appearance(g/kg/d)
Measured: one week after the washout period
biochemical indicators
normalized protein equivalent of total nitrogen appearance(g/kg/d)
Measured: the end of the 7-days-study period
biochemical indicators
pre-Alb(mg/dL)
Measured: baseline
biochemical indicators
pre-Alb(mg/dL)
Measured: one week after the washout period
biochemical indicators
pre-Alb(mg/dL)
Measured: the end of the 7-days-study period
biochemical indicators
ferritin(ng/mL)
Measured: baseline
biochemical indicators
ferritin(ng/mL)
Measured: one week after the washout period
biochemical indicators
ferritin(ng/mL)
Measured: the end of the 7-days-study period
biochemical indicators
red blood cell (10^6/μL), white blood count(10^3/μL)
Measured: baseline
biochemical indicators
red blood cell (10^6/μL), white blood count(10^3/μL)
Measured: one week after the washout period
biochemical indicators
red blood cell (10^6/μL), white blood count(10^3/μL)
Measured: the end of the 7-days-study period
biochemical indicators
Hb (g/dL)
Measured: baseline
biochemical indicators
Hb (g/dL)
Measured: one week after the washout period
biochemical indicators
Hb (g/dL)
Measured: the end of the 7-days-study period
biochemical indicators
Hct (%)
Measured: baseline
biochemical indicators
Hct (%)
Measured: one week after the washout period
biochemical indicators
Hct (%)
Measured: the end of the 7-days-study period
biochemical indicators
FGF23
Measured: baseline
biochemical indicators
FGF23
Measured: one week after the washout period
biochemical indicators
FGF23
Measured: the end of the 7-days-study period
biochemical indicators
iPTH (pg/mL)
Measured: baseline
biochemical indicators
iPTH (pg/mL)
Measured: one week after the washout period
biochemical indicators
iPTH (pg/mL)
Measured: the end of the 7-days-study period
biochemical indicators
blood urea nitrogen(mg/dL) , creatinine(mg/dL) , uric acid(mg/dL)
Measured: baseline
biochemical indicators
blood urea nitrogen(mg/dL) , creatinine(mg/dL) , uric acid(mg/dL)
Measured: one week after the washout period
biochemical indicators
blood urea nitrogen(mg/dL) , creatinine(mg/dL) , uric acid(mg/dL)
Measured: the end of the 7-days-study period
biochemical indicators
estimated glomerular filtration rate (ml/min/1.73m^2)
Measured: baseline
biochemical indicators
estimated glomerular filtration rate (ml/min/1.73m^2)
Measured: one week after the washout period
biochemical indicators
estimated glomerular filtration rate (ml/min/1.73m^2)
Measured: the end of the 7-days-study period
inflammation indicators
C reactive protein (mg/dL)
Measured: baseline
inflammation indicators
C reactive protein (mg/dL)
Measured: one week after the washout period
inflammation indicators
C reactive protein (mg/dL)
Measured: the end of the 7-days-study period
inflammation indicators
interleukin-1 (pg/mL) , interleukin-6 (pg/mL) , tumor necrosis factor-α (pg/mL)
Measured: baseline
inflammation indicators
interleukin-1 (pg/mL) , interleukin-6 (pg/mL) , tumor necrosis factor-α (pg/mL)
Measured: one week after the washout period
inflammation indicators
interleukin-1 (pg/mL) , interleukin-6 (pg/mL) , tumor necrosis factor-α (pg/mL)
Measured: the end of the 7-days-study period
Electrolyte
P(mg/dL), Ca(mg/dL), Mg(mg/dL)
Measured: baseline
Electrolyte
P(mg/dL), Ca(mg/dL), Mg(mg/dL)
Measured: one week after the washout period
Electrolyte
P(mg/dL), Ca(mg/dL), Mg(mg/dL)
Measured: the end of the 7-days-study period
Electrolyte
K(mEq/L), Na(mEq/L)
Measured: baseline
Electrolyte
K(mEq/L), Na(mEq/L)
Measured: one week after the washout period
Electrolyte
K(mEq/L), Na(mEq/L)
Measured: the end of the 7-days-study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start3 Dec 2020 (estimated)
- Primary completion28 May 2021 (estimated)
- Study completion28 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis PatientsStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mai-Szu Wu, Principal investigator, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645459
- Sponsor's protocol ID
- N202004062
- Status last verified
- May 2020
- First submitted
- 15 Oct 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Low Phosphorus Meals on Serum Phosphorus Concentration and Inflammatory Indicators in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT04645459
- Acronym / sponsor ID
- N202004062
- Conditions
- Hemodialysis Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 3 Dec 2020 (estimated)
- Primary completion
- 28 May 2021 (estimated)
- Study completion
- 28 May 2021 (estimated)
- First posted
- 27 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Consuming high levels of dietary phosphate and poor adherence of phosphate-binding-therapy might induce hyperphosphatemia in the hemodialysis (HD) patients. Therefore, the risks of Chronic Kidney Disease-related Mineral and Bone Disorders (CKD-MBDs) and inflammation will be increased. This double blind and intervention randomized controlled trial study will be designed to investigate the hypothesis that if low phosphorus meals decrease serum phosphorus concentration and inflammatory indicators. A total of 80 HD patients in the HD center of Shuang Ho Hospital will be recruited and be assigned to low phosphorus meal group (LP group) and control group randomly before one-week-washout period. The subjects of LP group and control group will consume low phosphorus meals and standard meals respectively. During washout period and study period, all subjects will continue to consume their regular breakfast and take one tablet of calcium carbonate with meal. All data will be collected at baseline, one week after the washout period, and the end of the 7-days-study period. The indicators are including dietary contents, phosphate binder administration, indicators of dialysis adequacy, nutritional indicators, blood lipid indicators, biochemical indicators, CKD-MBDs indicators, and inflammation indicators. Data were analyzed by Statistical Product and Service Solutions program version 18. Paired t-test, Student's t-test, Pearson correlation coefficient and Logistic regression will be used. P < 0.05 will be considered as statistically significant.
Detailed description
Study Design and Subjects:
This study was design as a randomized, double-blind control trail. A total of 80 HD patients were recruited from the HD center of Taipei Medical University-Shuang Ho Hospital in Taiwan. The inclusion criteria were including ≧20 years old and non vegetarian. The exclusion criteria are including liver dysfunction, cancer and pregnancy.
Dietary Intervention:
All subjects followed their usual diets but took one tablet of calcium carbonate as phosphate binder per meal for the first week washout diet. After washout diet, subjects were assign to control or study group randomly and entered to the study period for one week. The diets of the study group were low phosphorus ( LP group), but the dietary phosphorous levels of the control group were not modified. During the study period, all subjects including LP group and control group still kept their usually accustomed behavior about regular breakfast and also took one tablet of calcium carbonate as phosphate binder with every breakfast meal. The LP group and control group replaced daily lunch and dinner with low phosphorus and standard meals respectively and should not take any phosphate binder during the study period for one week.
For controlling the volumes of proteins, phosphorus and calcium easily, the main courses of both of the study and the control meals were made by a central kitchen. All of the meals contained 3 exchanges of protein (25 g) and 1 exchange of vegetable. There were 5 main courses for the both diets. The proteins of the study meals had been removed by an average 20 -30% of the phosphorus through boiling the meats before cooking process. But the boiling method did not process for the control meals. Every meal including all the study and the control meals contained one tablet of calcium carbonate. As a consequence, the additional phosphate binders should not be taken while eating the study meals. The subjects had to prepare carbohydrate by themselves, and they could choose any source of carbohydrate as their wants.
Data Collection:
The personal characteristics and the anthropometry data were collected at baseline. All data were collected at baseline, one week after the washout period, and the end of the 7-days-study period. The indicators were including dietary contents, phosphate binder administration, dialysis adequacy, nutritional indicators, blood lipid indicators, biochemical indicators, CKD-MBDs indicators, and inflammation indicators.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low phosphorus meal group (LP group) | Experimental | Other: low phosphorus mealsThe proteins of the low phosphorus meal had been removed by an average 20 -30% of the phosphorus through boiling the meats before cooking process. |
| control group | Placebo comparator | Other: control mealsThe boiling method did not process for the control meals. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hemodialysis patients, ≥ 20 years of age
Key exclusion criteria (1 listed)
- ≥ 80 years of age, liver cirrhosis, cancer, pregnancy, vegetarian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low phosphorus mealsAll subjects followed their usual diets but took one tablet of calcium carbonate as phosphate binder per meal for the first week washout diet. After washout diet, subjects were assign to control or study group randomly and entered to the study period for one week. The diets of the study group were low phosphorus ( LP group), but the dietary phosphorous levels of the control group were not modified. During the study period, all subjects including LP group and control group still kept their usually accustomed behavior about regular breakfast and also took one tablet of calcium carbonate as phosphate binder with every breakfast meal. The LP group and control group replaced daily lunch and dinner with low phosphorus and standard meals respectively and should not take any phosphate binder during the study period for one week. | Other | low phosphorus meal group (LP group) |
| control mealsAll subjects followed their usual diets but took one tablet of calcium carbonate as phosphate binder per meal for the first week washout diet. After washout diet, subjects were assign to control or study group randomly and entered to the study period for one week. The diets of the study group were low phosphorus ( LP group), but the dietary phosphorous levels of the control group were not modified. During the study period, all subjects including LP group and control group still kept their usually accustomed behavior about regular breakfast and also took one tablet of calcium carbonate as phosphate binder with every breakfast meal. The LP group and control group replaced daily lunch and dinner with low phosphorus and standard meals respectively and should not take any phosphate binder during the study period for one week. | Other | control group |
Primary outcome
anthropometric measurement
Time frame: baseline
body height (cm)
anthropometric measurement
Time frame: one week after the washout period
body height (cm)
anthropometric measurement
Time frame: the end of the 7-days-study period
body height (cm)
anthropometric measurement
Time frame: baseline
body weight before hemodialysis (Kg), dry weight (Kg)
anthropometric measurement
Time frame: one week after the washout period
body weight before hemodialysis (Kg), dry weight (Kg)
anthropometric measurement
Time frame: the end of the 7-days-study period
body weight before hemodialysis (Kg), dry weight (Kg)
blood pressure
Time frame: baseline
systolic blood pressure (mmHg), diastolic blood pressure (mmHg)
blood pressure
Time frame: one week after the washout period
systolic blood pressure (mmHg), diastolic blood pressure (mmHg)
blood pressure
Time frame: the end of the 7-days-study period
systolic blood pressure (mmHg), diastolic blood pressure (mmHg)
dietary contents
Time frame: baseline
24-hour dietary recall
dietary contents
Time frame: one week after the washout period
24-hour dietary recall
dietary contents
Time frame: the end of the 7-days-study period
24-hour dietary recall
phosphate binder administration
Time frame: baseline
type and dosing frequency
phosphate binder administration
Time frame: one week after the washout period
type and dosing frequency
phosphate binder administration
Time frame: the end of the 7-days-study period
type and dosing frequency
indicators of dialysis adequacy
Time frame: baseline
Kt/V
indicators of dialysis adequacy
Time frame: one week after the washout period
Kt/V
indicators of dialysis adequacy
Time frame: the end of the 7-days-study period
Kt/V
blood lipid indicators
Time frame: baseline
LDL(mg/dL), HDL (mg/dL) , cholesterol (mg/dL) , triglyceride (mg/dL)
blood lipid indicators
Time frame: one week after the washout period
LDL(mg/dL), HDL (mg/dL) , cholesterol (mg/dL) , triglyceride (mg/dL)
blood lipid indicators
Time frame: the end of the 7-days-study period
LDL(mg/dL), HDL (mg/dL) , cholesterol (mg/dL) , triglyceride (mg/dL)
biochemical indicators
Time frame: baseline
normalized protein equivalent of total nitrogen appearance(g/kg/d)
biochemical indicators
Time frame: one week after the washout period
normalized protein equivalent of total nitrogen appearance(g/kg/d)
biochemical indicators
Time frame: the end of the 7-days-study period
normalized protein equivalent of total nitrogen appearance(g/kg/d)
biochemical indicators
Time frame: baseline
pre-Alb(mg/dL)
biochemical indicators
Time frame: one week after the washout period
pre-Alb(mg/dL)
biochemical indicators
Time frame: the end of the 7-days-study period
pre-Alb(mg/dL)
biochemical indicators
Time frame: baseline
ferritin(ng/mL)
biochemical indicators
Time frame: one week after the washout period
ferritin(ng/mL)
biochemical indicators
Time frame: the end of the 7-days-study period
ferritin(ng/mL)
biochemical indicators
Time frame: baseline
red blood cell (10^6/μL), white blood count(10^3/μL)
biochemical indicators
Time frame: one week after the washout period
red blood cell (10^6/μL), white blood count(10^3/μL)
biochemical indicators
Time frame: the end of the 7-days-study period
red blood cell (10^6/μL), white blood count(10^3/μL)
biochemical indicators
Time frame: baseline
Hb (g/dL)
biochemical indicators
Time frame: one week after the washout period
Hb (g/dL)
biochemical indicators
Time frame: the end of the 7-days-study period
Hb (g/dL)
biochemical indicators
Time frame: baseline
Hct (%)
biochemical indicators
Time frame: one week after the washout period
Hct (%)
biochemical indicators
Time frame: the end of the 7-days-study period
Hct (%)
biochemical indicators
Time frame: baseline
FGF23
biochemical indicators
Time frame: one week after the washout period
FGF23
biochemical indicators
Time frame: the end of the 7-days-study period
FGF23
biochemical indicators
Time frame: baseline
iPTH (pg/mL)
biochemical indicators
Time frame: one week after the washout period
iPTH (pg/mL)
biochemical indicators
Time frame: the end of the 7-days-study period
iPTH (pg/mL)
biochemical indicators
Time frame: baseline
blood urea nitrogen(mg/dL) , creatinine(mg/dL) , uric acid(mg/dL)
biochemical indicators
Time frame: one week after the washout period
blood urea nitrogen(mg/dL) , creatinine(mg/dL) , uric acid(mg/dL)
biochemical indicators
Time frame: the end of the 7-days-study period
blood urea nitrogen(mg/dL) , creatinine(mg/dL) , uric acid(mg/dL)
biochemical indicators
Time frame: baseline
estimated glomerular filtration rate (ml/min/1.73m^2)
biochemical indicators
Time frame: one week after the washout period
estimated glomerular filtration rate (ml/min/1.73m^2)
biochemical indicators
Time frame: the end of the 7-days-study period
estimated glomerular filtration rate (ml/min/1.73m^2)
inflammation indicators
Time frame: baseline
C reactive protein (mg/dL)
inflammation indicators
Time frame: one week after the washout period
C reactive protein (mg/dL)
inflammation indicators
Time frame: the end of the 7-days-study period
C reactive protein (mg/dL)
inflammation indicators
Time frame: baseline
interleukin-1 (pg/mL) , interleukin-6 (pg/mL) , tumor necrosis factor-α (pg/mL)
inflammation indicators
Time frame: one week after the washout period
interleukin-1 (pg/mL) , interleukin-6 (pg/mL) , tumor necrosis factor-α (pg/mL)
inflammation indicators
Time frame: the end of the 7-days-study period
interleukin-1 (pg/mL) , interleukin-6 (pg/mL) , tumor necrosis factor-α (pg/mL)
Electrolyte
Time frame: baseline
P(mg/dL), Ca(mg/dL), Mg(mg/dL)
Electrolyte
Time frame: one week after the washout period
P(mg/dL), Ca(mg/dL), Mg(mg/dL)
Electrolyte
Time frame: the end of the 7-days-study period
P(mg/dL), Ca(mg/dL), Mg(mg/dL)
Electrolyte
Time frame: baseline
K(mEq/L), Na(mEq/L)
Electrolyte
Time frame: one week after the washout period
K(mEq/L), Na(mEq/L)
Electrolyte
Time frame: the end of the 7-days-study period
K(mEq/L), Na(mEq/L)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mai-Szu Wu principal investigator
Taipei Medical University Shuang Ho Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low phosphorus meals in people with Hemodialysis Patients, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara Y.J. Chen (+886963358528, d507103001@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anthropometric measurement (time frame: baseline). The study lists 63 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.